FDA.reportPublic FDA data

APC™ Flash-Free SmartClip™ SL3

Primary DI
00652221226990
Brand
APC™ Flash-Free SmartClip™ SL3
Company
3M UNITEK CORPORATION
Model
4004-135
Catalog number
4004-135
Device description
SmartClip(TM) SL3 Self-Ligating Bracket APC(TM) Flash-Free Ricketts/High Torque VPO U/L 5x5 .018 Kt
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221226990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221226990006522212269906522212269900652221226990

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)423-45883Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
008256356
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006522210018183M™ Unitek™ Metal Brackets001--227001--2272026-05-07
006522210247323M™ Unitek™ Lingual Sheaths080--216080--2162026-05-07
006522210366983M™ Unitek™ Orthodontic Bands141--000141--0002026-05-07
006522210388693M™ Unitek™ Orthodontic Bands149--000149--0002026-05-07
006522210444403M™ Unitek™ Orthodontic Bands160--000160--0002026-05-07
006522210472503M™ Unitek™185--120185--1202026-05-07
006522210472743M™ Unitek™185--122185--1222026-05-07
006522210473803M™ Unitek™185--133185--1332026-05-07
006522210670363M™ Unitek™ Intraoral Attachments309--151309--1512026-05-07
006522210670433M™ Unitek™ Intraoral Attachments309--152309--1522026-05-07
006522210670503M™ Unitek™ Intraoral Attachments309--153309--1532026-05-07
006522210670743M™ Unitek™ Intraoral Attachments309--155309--1552026-05-07
006522210671113M™ Unitek™ Intraoral Attachments309--158309--1582026-05-07
006522210671283M™ Unitek™ Intraoral Attachments309--159309--1592026-05-07
006522210671423M™ Unitek™ Intraoral Attachments309--161309--1612026-05-07
006522210671593M™ Unitek™ Intraoral Attachments309--162309--1622026-05-07
006522210671663M™ Unitek™ Intraoral Attachments309--163309--1632026-05-07
006522210713163M™ Unitek™ Intraoral Attachments340--017340--0172026-05-07
006522210713233M™ Unitek™ Intraoral Attachments340--018340--0182026-05-07
006522210713303M™ Unitek™ Intraoral Attachments340--019340--0192026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479203652EXCEL REGULARRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-13
07290115050035High-Q-Bond Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051896Ideal 1 Orthodontic Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051902High-Q-Bond BandB.J.M. LABORATORIES LTDDYH2026-03-13
00840479203317RELY A BONDRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-12
00840479202372PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202389PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202396PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202402PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202419PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202426PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202433PLASTIC CONDITIONERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202440PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202457PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202464PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202570PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479201894LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201900LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201924LIGHT BOND THIN PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201931LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201948LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201979LIGHT BOND REGULAR SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201986LIGHT BOND MEDIUM PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201993LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202006LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202082MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202099MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202105MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202136METAL PRIMERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202259PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10